Trial Outcomes & Findings for Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study (NCT NCT02308124)
NCT ID: NCT02308124
Last Updated: 2021-10-19
Results Overview
Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.
COMPLETED
PHASE4
87 participants
after 3-month medical treatment
2021-10-19
Participant Flow
Participant milestones
| Measure |
Midodrine Only
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
|
Pyridostigmine Only
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
|
Midodrine + Pyridostigmine
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
29
|
|
Overall Study
COMPLETED
|
23
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
8
|
Reasons for withdrawal
| Measure |
Midodrine Only
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
|
Pyridostigmine Only
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
|
Midodrine + Pyridostigmine
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
6
|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
Baseline Characteristics
Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study
Baseline characteristics by cohort
| Measure |
Midodrine Only
n=29 Participants
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
|
Pyridostigmine Only
n=29 Participants
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
|
Midodrine + Pyridostigmine
n=29 Participants
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 17.7 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 16.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
29 participants
n=5 Participants
|
87 participants
n=4 Participants
|
|
Supine systolic blood pressure
|
137.3 mmHg
STANDARD_DEVIATION 20.9 • n=5 Participants
|
124.5 mmHg
STANDARD_DEVIATION 18.5 • n=7 Participants
|
122.0 mmHg
STANDARD_DEVIATION 15.6 • n=5 Participants
|
127.9 mmHg
STANDARD_DEVIATION 19.4 • n=4 Participants
|
|
Supine diastolic blood pressure
|
83.2 mmHg
STANDARD_DEVIATION 12.8 • n=5 Participants
|
76.5 mmHg
STANDARD_DEVIATION 9.8 • n=7 Participants
|
76.9 mmHg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
78.9 mmHg
STANDARD_DEVIATION 11.4 • n=4 Participants
|
|
Supine heart rate
|
68.0 Beats per Minute
STANDARD_DEVIATION 11.3 • n=5 Participants
|
66.7 Beats per Minute
STANDARD_DEVIATION 13.5 • n=7 Participants
|
67.0 Beats per Minute
STANDARD_DEVIATION 10.7 • n=5 Participants
|
67.2 Beats per Minute
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Orthostatic systolic blood pressure change
|
-24.7 mmHg
STANDARD_DEVIATION 9.9 • n=5 Participants
|
-23.3 mmHg
STANDARD_DEVIATION 12.5 • n=7 Participants
|
-22.5 mmHg
STANDARD_DEVIATION 10.1 • n=5 Participants
|
-23.5 mmHg
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Orthostatic diastolic blood pressure change
|
-13.4 mmHg
STANDARD_DEVIATION 9.0 • n=5 Participants
|
-15.5 mmHg
STANDARD_DEVIATION 9.9 • n=7 Participants
|
-13.4 mmHg
STANDARD_DEVIATION 8.2 • n=5 Participants
|
-14.1 mmHg
STANDARD_DEVIATION 9.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: after 3-month medical treatmentPopulation: At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.
Outcome measures
| Measure |
Midodrine Only
n=23 Participants
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
|
Pyridostigmine Only
n=21 Participants
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
|
Midodrine + Pyridostigmine
n=21 Participants
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
|
|---|---|---|---|
|
Change in Orthostatic BP Drop
Changes in DBP drop
|
7.5 mmHg
Standard Deviation 15.3
|
11.1 mmHg
Standard Deviation 17.7
|
7.4 mmHg
Standard Deviation 14.2
|
|
Change in Orthostatic BP Drop
Changes in SBP drop
|
11.1 mmHg
Standard Deviation 16.9
|
13.6 mmHg
Standard Deviation 20.1
|
8.9 mmHg
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: after 3-month medical treatment.Population: At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results. OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity. \*\* OHQ total score minimal 0 \~ maximal 100
Outcome measures
| Measure |
Midodrine Only
n=23 Participants
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
|
Pyridostigmine Only
n=21 Participants
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
|
Midodrine + Pyridostigmine
n=21 Participants
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
|
|---|---|---|---|
|
Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).
|
-16.2 points
Standard Deviation 15.5
|
-17.2 points
Standard Deviation 20.3
|
-12.6 points
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: after 3-month medical treatment.Population: At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
Change of the depression score after 3-month medical treatment compared to initial results. 21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression. Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63
Outcome measures
| Measure |
Midodrine Only
n=23 Participants
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
|
Pyridostigmine Only
n=21 Participants
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
|
Midodrine + Pyridostigmine
n=21 Participants
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
|
|---|---|---|---|
|
Change of the Depression Score (Beck Depression Inventory-II )
|
-6.8 points
Standard Deviation 5.6
|
-7.8 points
Standard Deviation 6.5
|
-3.5 points
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: changes at 3 months after treatmentPopulation: At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores.
Outcome measures
| Measure |
Midodrine Only
n=23 Participants
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
|
Pyridostigmine Only
n=21 Participants
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
|
Midodrine + Pyridostigmine
n=21 Participants
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
|
|---|---|---|---|
|
Short-form 36 Version 2
|
5.6 points
Standard Deviation 6.8
|
4.2 points
Standard Deviation 9.1
|
2.7 points
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: changes at 3 months after treatmentPopulation: At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)
changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS) SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores.
Outcome measures
| Measure |
Midodrine Only
n=23 Participants
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
|
Pyridostigmine Only
n=21 Participants
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
|
Midodrine + Pyridostigmine
n=21 Participants
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
|
|---|---|---|---|
|
Changes in Health-related Quality of Life
|
5.0 points
Standard Deviation 8.6
|
6.7 points
Standard Deviation 8.9
|
0.4 points
Standard Deviation 11.2
|
Adverse Events
Midodrine Only
Pyridostigmine Only
Midodrine + Pyridostigmine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Midodrine Only
n=29 participants at risk
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
|
Pyridostigmine Only
n=29 participants at risk
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
|
Midodrine + Pyridostigmine
n=29 participants at risk
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
6.9%
2/29 • Number of events 2 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
0.00%
0/29 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
|
Nervous system disorders
dizziness
|
3.4%
1/29 • Number of events 1 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
17.2%
5/29 • Number of events 5 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
3.4%
1/29 • Number of events 1 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/29 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
6.9%
2/29 • Number of events 2 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
6.9%
2/29 • Number of events 2 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
|
Nervous system disorders
tremor
|
0.00%
0/29 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
3.4%
1/29 • Number of events 1 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
0.00%
0/29 • Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place